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Equipment Validation

Public Course

This Equipment Validation  course is a 2 Day public programme, designed to provide participants with basic principles of validation with focus on equipment validation. This Equipment Validation course will provide attendees information on preparing a master plan, associated protocols, and reports.

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695.00

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Course Content:

  • Introduction & Course Objectives
  • Introduction
  • Business Benefits of Equipment Validation
  • Regulatory Requirements & Guidelines
  • Validation Master Plan
  • Validation versus Verification
  • Statistical Methods & Tools for Validation
  • ISO 14971 & Risk Assessment
  • Equipment Qualification (IQ, OQ, PQ)
  • Cleaning Validation
  •  Product & Process Validation
  • 21 CFR Part 11 – Electronic Signatures & Records
  • Case study & exercise
  • Preparing a Validation Master Plan
  • Preparing a Equipment Validation Protocol
  • Preparing a Process Validation Report
  • Maintaining a state of validation
  • Retrospective Validation
  • Review of recent FDA Warning Letters
  • Q&A
  • Conclude & Follow Up Process

This Equipment Validation training programme may be of interest to all personnel directly involved in equipment validation, as well as, new or seasoned operational personnel who will eventually participate in such efforts. Individuals in management who interact with the above or interact with regulatory agency inspectors to rationalise or defend validation programs will also benefit from attending this course.

Classroom based, instructor lead, practical hands on course.

Product Description

This Equipment Validation  course is a 2 Day public programme, designed to provide participants with basic principles of validation with focus on equipment validation. This Equipment Validation course will provide attendees information on preparing a master plan, associated protocols, and reports.

Awarding Body: Optima Training & Consulting Ltd

National Framework of Qualifications Level: N/a

Certification: Optima Training & Consulting Ltd Certificate of Completion

Renewal: N/a

Entry Requirements:
Minimum age- 18 years old

Minimum English requirements: Leaners must be able to understand and convey the concepts contained in the programme content.

Assessment Details: Class Interaction

Cost Per Person:
The fee is inclusive of all training courseware materials, certificate of completion and 3 months after training support.

Progression Opportunities: Please see related courses

Protection for Enrolled Students: N/A

Should a course not proceed, any payment received will be refunded within 48 hours